Department of Rheumatology, Martina Hansens Hospital, Gjettum, Norway
Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
RMD Open. 2024 Aug 19;10(3):e004395. doi: 10.1136/rmdopen-2024-004395.
To compare the sensitivity of 2019 European Alliance of Associations for Rheumatology/American College of Rheumatology (EULAR/ACR) classification criteria against 1997 ACR criteria for systemic lupus erythematosus (SLE), for incident SLE cases in the presumably complete population-based Nor-SLE cohort from Southeast Norway (2.9 million inhabitants).
All cases International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) coded as SLE during 2000-2017 were individually reviewed. Those with a confirmed SLE diagnosis by expert clinical assessment were included in the Nor-SLE cohort. Core clinical data were recorded, and the cases were classified according to 2019 EULAR/ACR and 1997 ACR criteria. Juvenile SLE was defined as <16 years at diagnosis and adult SLE was defined as ≥16 years at diagnosis.
We included 737 incident SLE cases (701 adults, 36 juveniles). At diagnosis, 2019 EULAR/ACR criteria were more sensitive than 1997 ACR criteria for adults (91.6% vs 77.3%; p<0.001), but not for juveniles (97.2% vs 88.9%). The 2019 EULAR/ACR counts at diagnosis differed by age group and ethnicity, being higher in young cases and those originating from Asia. From time of diagnosis to study end the fulfilment rate of 2019 EULAR/ACR criteria for the adult cohort increased from 92.5% and 86.5% to 94.6% and 91.0%, respectively, for females and males (mean disease duration of 7.5 years).
Showing 92% criteria fulfilment already at time of SLE diagnosis by 2019 EULAR/ACR criteria versus 77% by 1997 ACR criteria, the results from this population-based study suggest that the 2019 EULAR/ACR criteria will achieve its goal of capturing more early-SLE cases for clinical trials.
比较 2019 年欧洲抗风湿病联盟/美国风湿病学会(EULAR/ACR)分类标准与 1997 年美国风湿病学会(ACR)系统性红斑狼疮(SLE)标准对挪威东南部可能完整的基于人群的 Nor-SLE 队列中(290 万居民)新发 SLE 病例的敏感性。
对 2000-2017 年期间国际疾病分类第十版(ICD-10)编码为 SLE 的所有病例进行个体回顾。通过专家临床评估确诊的病例被纳入 Nor-SLE 队列。记录核心临床数据,并根据 2019 年 EULAR/ACR 和 1997 年 ACR 标准对病例进行分类。青少年 SLE 的定义为诊断时年龄<16 岁,成人 SLE 的定义为诊断时年龄≥16 岁。
我们纳入了 737 例新发 SLE 病例(701 例成人,36 例青少年)。在诊断时,2019 年 EULAR/ACR 标准对成人比 1997 年 ACR 标准更敏感(91.6%比 77.3%;p<0.001),但对青少年不敏感(97.2%比 88.9%)。2019 年 EULAR/ACR 在诊断时的分类计数因年龄组和种族而异,在年轻病例和亚洲来源的病例中更高。从诊断到研究结束,成年队列中 2019 年 EULAR/ACR 标准的达标率从女性和男性的 92.5%和 86.5%分别增加到 94.6%和 91.0%(平均疾病持续时间为 7.5 年)。
本基于人群的研究结果表明,2019 年 EULAR/ACR 标准在 SLE 诊断时已经达到 92%的标准达标率,而 1997 年 ACR 标准为 77%,这表明 2019 年 EULAR/ACR 标准将实现其为临床试验捕获更多早期 SLE 病例的目标。